Covid vaccines still face a few hurdles

Coronavirus Daily
Bloomberg

Covid vaccines still face a few hurdles

Pfizer Inc. and BioNTech SE now have the data they need and requested emergency authorization for their Covid vaccine on Friday that could lead to the shot's use by mid-December.

The race isn't over yet, though. It could take at least three weeks for a U.S. Food and Drug Administration decision as the trial data is probed by agency staff and outside advisers

The next key step is a meeting of FDA staff and outside advisers to sort through the data, and there are two key moments to watch. The first comes two days before the advisers meet, when the FDA typically releases its staff report on the clinical trial data. This will offer some insight into whether the agency is leaning toward authorizing the vaccine. The second is at the end of the meeting, when it will take a non-binding vote on whether FDA should clear the shot for public use.

The FDA staff will be combing through Pfizer's raw data, which the public doesn't have access to, rather than relying on the company's own results to determine the safety and efficacy of the vaccine. The agency and Pfizer will each summarize their findings for the advisory panel.

Moderna Inc. has also released positive interim results from a final-stage trial and has said it's close to seeking emergency authorization of its Covid-19 vaccine. It's unclear whether the shot could be considered alongside Pfizer's during the advisory committee meeting.

Emergency authorization allows drugs and vaccines targeting Covid-19 to reach Americans much faster than through standard approval channels. The FDA review process normally takes about six to 10 months, depending on the candidate's priority status.

And the FDA isn't the only U.S. agency that needs to consider the vaccines. Another group of advisers for the Centers for Disease Control and Prevention also must meet on the vaccine and make recommendations as to who should be first in line to get it. The timing of this meeting is unclear.

Following those steps, the vaccine can start rolling out. Pfizer and federal and state government officials are preparing to help distribute the vaccine within days of an FDA emergency authorization. Help will be on its way.--Anna Edney

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Photographer: Patricia Suzara

Photographer: Patricia Suzara

 

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